Masimo Receives FDA Clearance for Noninvasive Total Hemoglobin

May 16, 2008

Masimo received FDA clearance in May 2008 for its noninvasive and continuous total hemoglobin monitoring technology (SpHb).

The company said the availability of its SpHb technology should make hemoglobin measurement more convenient and broadly available to clinicians in both hospital and outpatient settings, helping them make earlier and better clinical decisions, improve patient safety and decrease costs. Noninvasive total hemoglobin will be offered as part of the upgradable Masimo Rainbow SET technology platform.

“Management of appropriate blood levels is vitally important to sustain life,” said Ronald Miller, M.D., professor and chair of the department of anesthesia and perioperative care at the University of California at San Francisco. “Without up-to-date hemoglobin levels, patient bleeding in the operating room, recovery room, intensive care or trauma departments, where blood loss is common, can often go undetected until it poses critical short and long-term dangers to health and recovery. The ability to immediately and continuously measure hemoglobin levels will facilitate the timely administration of appropriate blood products. Conversely, during surgery, because blood is a precious and costly resource, continuously measuring hemoglobin levels noninvasively can help clinicians avoid unnecessary blood transfusions and decrease costs by more effectively titrating blood and blood replacement products.”

The need for better hemoglobin monitoring to manage blood levels is reinforced by recently published controlled studies that show the safety of blood transfusions can be improved by the use of transfusion thresholds. In a 2008 study by the Cochrane Collaboration titled “Transfusion Thresholds and Other Strategies for Guiding Allogeneic Red Blood Cell Transfusion,” reviewers examined evidence from 10 trials, reporting outcomes on a total of 1,780 patients, and found that restrictive transfusion strategies reduced red blood cell transfusions by 42 percent.

Additionally, while noting that not all of these results were statistically significant and that additional studies are required to confirm the findings, the Cochrane reviewers also reported, “on average, mortality was 20 percent lower with the restrictive compared with the liberal transfusion triggers.” Similarly, five of the 10 studies examined showed a reduction in hospital length of stay, while three showed a reduction in ICU length of stay.